FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 3
MDR report key: 2758216
·
Received September 18, 2012
Report
- Report Number
- 1811755-2012-03541
- Event Type
- Malfunction
- Date Received
- September 18, 2012
- Date of Event
- August 29, 2012
- Report Date
- August 29, 2012
- Manufacturer
- STRYKER INSTRUMENTS, INSTRUMENTS DIV.
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS AVAILABLE FOR EVAL BUT HAS NOT YET BEEN RECEIVED. ADD¿L INFO WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CORDLESS DRIVER 3 WAS LEAKING DURING A PROCEDURE. NOTHING LEAKED INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH A READILY AVAILABLE ALTERNATE DEVICE WITHOUT ANY PROCEDURE DELAY. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDLESS DRIVER 3 | HRX | STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |